We TRACC Global are your go to medical device solution.Our commitment to excellence extends beyond product development. Collaboration is at the core of our ethos.
Conducting impact assessments: TRACC Global helps clients assess the impact of regulatory changes or updates on their existing regulatory files, ensuring ongoing compliance.
Remediation support: team assists clients in addressing any gaps or deficiencies identified during regulatory inspections or audits, providing guidance on remediation strategies.
Regulatory file maintenance: TRACC Global helps clients maintain their regulatory files, ensuring that they are up to date, accurate, and compliant with applicable regulations.
Indian MDR 2017 compliance: TRACC Global provides regulatory support to clients in aligning their medical devices with the Indian Medical Device Rules 2017 (MDR 2017).
Local authority submissions: team assists clients in preparing and submitting necessary documentation to the Indian regulatory authorities for compliance assessments, approvals, and registrations.
WHO PQ compliance: TRACC Global provides regulatory support to clients seeking compliance with the World Health Organization Prequalification (PQ) requirements for medical devices or diagnostics.
Documentation and processes: team assists in preparing the necessary documentation, quality management systems, and product performance data to meet WHO PQ standards.
Regulatory training programs: TRACC Global offers customized regulatory training sessions to educate clients on relevant regulations, compliance requirements, and best practices.
Workshops and seminars: team conducts workshops and seminars to enhance clients' understanding of regulatory processes, updates, and industry-specific regulatory challenges.
Global device registration: TRACC Global provides consultancy services for device registration in various countries, including Thailand, Vietnam, USA, UK, and others.
Regulatory expertise: team leverages their regulatory expertise and knowledge of local requirements to support clients throughout the registration process in target countries.
Documentation preparation: TRACC Global assists clients in preparing technical files, dossiers, and Drug Master Files (DMFs) required for regulatory submissions.
Compliance support: The team ensures that the documentation meets the regulatory standards and guidelines for product registration or approval. Please note that the specific details and requirements for each service may vary based on the country, industry, and regulatory authorities involved. Team TRACC Global aims to provide tailored support to meet the specific needs of their clients in various regulatory domains.
